[Federal Register Volume 68, Number 162 (Thursday, August 21, 2003)]
[Notices]
[Pages 50542-50543]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-21399]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

    Periodically, the Health Resources and Services Administration 
(HRSA) publishes abstracts of information collection requests under 
review by the Office of Management and Budget, in compliance with the 
Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35). To request a 
copy of the clearance requests submitted to OMB for review, call the 
HRSA Reports Clearance Office on (301)-443-1129.
    The following request has been submitted to the Office of 
Management and Budget for review under the Paperwork Reduction Act of 
1995:

Proposed Project: Drug Pricing Program Reporting Requirements (OMB No. 
0915-0176)--Revision

    Section 602 of Pub. L. 102-585, the Veterans Health Care Act of 
1992, enacted section 340B of the Public Health Service Act (PHS Act), 
``Limitation on Prices of Drugs Purchased by Covered Entities.'' 
Section 340B provides that a manufacturer who sells covered outpatient 
drugs to eligible entities must sign a pharmaceutical pricing agreement 
with the Secretary of Health and Human Services in which the 
manufacturer agrees to charge a price for covered outpatient drugs that 
will not exceed an amount determined under a statutory formula.
    Covered entities which choose to participate in the section 340B 
drug discount program must comply with the requirements of section 
340B(a)(5) of the PHS Act. Section 340B(a)(5)(A) prohibits a covered 
entity from accepting a discount for a drug that would also generate a 
Medicaid rebate. Further, section 340B(a)(5)(B) prohibits a covered 
entity from reselling or otherwise transferring a discounted drug to a 
person who is not a patient of the entity.
    In response to the statutory mandate of section 340B(a)(5)(C) to 
develop audit guidelines and because of the potential for disputes 
involving covered entities and participating drug manufacturers, the 
HRSA Pharmacy Affairs Branch (PAB) has developed a dispute resolution 
process for manufacturers and covered entities as well as manufacturer 
guidelines for audit of covered entities.
    Audit guidelines: A manufacturer will be permitted to conduct an 
audit only when there is reasonable cause to believe a violation of 
section 340B(a)(5)(A) or (B) has occurred. The manufacturer must notify 
the covered entity in writing when it believes the covered entity has 
violated the provisions of section 340B. If the problem cannot be 
resolved, the manufacturer must then submit an audit work plan 
describing the audit and evidence in support of the reasonable cause 
standard to the HRSA PAB for review. The office will review the 
documentation to determine if reasonable cause exist. Once the audit is 
completed, the manufacturer will submit copies of the audit report to 
the HRSA PAB for review and resolution of the findings, as appropriate. 
The manufacturer will also submit an informational copy of the audit 
report to the HHS Office of Inspector General.
    Dispute resolution guidelines: Because of the potential for 
disputes involving covered entities and participating drug 
manufacturers, the HRSA PAB has developed an informal dispute 
resolution process which can be used if an entity or manufacturer is 
believed to be in violation of section 340B. Prior to filing a request 
for resolution of a dispute with the HRSA PAB, the parties must 
attempt, in good faith, to resolve the dispute. All parties involved in 
the dispute must maintain written documentation as evidence of a good 
faith attempt to resolve the dispute. If the dispute is not resolved 
and dispute resolution is desired, a party must submit a written 
request for a review of the dispute to the HRSA PAB. A committee 
appointed to review the documentation will send a letter to the party 
alleged to have committed a violation. The party will be asked to 
provide a response to or a rebuttal of the allegations.
    To date, there have been no requests for audits, but two disputes 
have reached the level where a committee review may be needed. As a 
result, the estimates of annualized hour burden for audits and disputes 
have been reduced to the level shown in the table below.

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                                      No. of       Responses per       Total                       Total Burden
      Reporting Requirement         Respondents     Respondent       Responses    Hours/Response       Hours
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                                                     AUDITS
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Audit Notification of Entity \1\               2               1               2               4               8
---------------------------------
Audit Workplan \1\..............               1               1               1               8               8
Audit Report \1\................               1               1               1               1               1
Entity Response.................               0               0               0               0               0
---------------------------------
                                               DISPUTE RESOLUTION
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Mediation Request...............               2               4               8              10              80
Rebuttal........................               2               1               2              16              32
                                 -----------------
    TOTAL.......................               8             1.8              14             9.2            129
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\1\ Prepared by the manufacturer


[[Page 50543]]


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                                                                      No. of         Hours of
                    Recordkeeping requirement                      recordkeepers   recordkeeping   Total burden
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Dispute records.................................................              10              15               5
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    The total burden is 134 hours.
    Written comments and recommendations concerning the proposed 
information collection should be sent within 30 days of this notice to: 
Allison Eydt, Human Resources and Housing Branch, Office of Management 
and Budget, New Executive Office Building, Room 10235, Washington, DC 
20503 Fax Number 202-395-6974.

    Dated: August 15, 2003.
Jon L. Nelson,
Associate Administrator for Management and Program Support.
[FR Doc. 03-21399 Filed 8-20-03; 8:45 am]
BILLING CODE 4165-15-P